Medical Content Strategist

hace 5 días

Xico, México Syneos Health, Inc. A tiempo completo

About Us

Syneos Health, Inc. is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

We are passionate about developing our people through career development and progression, supportive line management, technical training, peer recognition, and total rewards program.

Our Total Self culture unites us globally, and we are dedicated to taking care of our people. We continuously build the company we all want to work for and our customers want to work with because diversity of thoughts, backgrounds, cultures, and perspectives create a place where everyone feels like they belong.

About the Role

This Medical Content Strategist will lead writing projects, mentor less experienced medical writers on complex projects, and manage medical writing activities associated with individual studies. The role involves coordinating medical writing activities within and across departments with minimal supervision.

The successful candidate will develop or support a variety of documents, including clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, annual reports, and integrated summary reports.

Key Responsibilities:

  • Mentor and lead less experienced medical writers on complex projects.
  • Act as lead for assigned writing projects.
  • Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
  • Develop or support a variety of documents, including clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, annual reports, and integrated summary reports.
  • Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
  • Review statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
  • Interact with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
  • Serve as peer reviewer on internal review team providing review comments on draft and final documents.
  • Adhere to established regulatory standards, including ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects.
  • Perform online clinical literature searches as applicable.
  • Maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
  • Maintain awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.

Requirements

To be successful in this role, you should have a Bachelor's degree in a relevant field, such as writing, communications, or sciences, with relevant experience. You should also possess strong proficiency in Microsoft Office, including Word, Excel, PowerPoint, and email.

You should be able to demonstrate high independence, effective presentation, proofreading, interpersonal, and leadership skills, and ensure a team-oriented approach. Additionally, you should have the ability to interpret and present complex information, including clinical data.

A salary range of $85,000 - $115,000 per year is estimated based on national averages for medical content strategist positions in Mexico.

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